Multiple sclerosis (MS) is generally known as an autoimmune disease of the central nervous system with both autoimmune and neurodegenerative features. It affects approximately 400,000 persons in the United States and 1.2 million persons worldwide. It is a major cause of neurological disability in young adults, who usually present with a relapsing, remitting pattern of neurologic involvement and progress to a chronic phase with increasing difficulty in ambulation and coordination. Studies have shown that nearly fifty percent of MS patients require an assistive device to walk after a decade of disease. Therefore, the societal impacts of both direct medical and indirect economic costs of MS are enormous and often imposed on young families.
Currently used drugs/agents for MS treatment either modify or suppress the body's immune system. They have been shown to modestly reduce neurological relapses of the disease and, in some instances, incompletely slow the progression of neurological disability. However, the vast majority of currently used drugs/agents for MS are variously limited by incomplete efficacy, side effects and medical risks, e.g., injection site reactions, including skin necrosis; flu-like symptoms; depression; psychosis; hypersensitivity; allergic reactions; cardiac and other organ toxicity from diabetes mellitus; cataracts; bone necrosis; serious and life threatening opportunistic infections, and risk of malignancy. The existence of these side effects and risks precludes the use of these drugs in many MS patients. Thus, there is a pressing need for therapeutic approaches/agents that are safe, efficacious, well-tolerated, and which can be administered more conveniently.